QC Scientist I

Job Description

Job Summary:

• QC Scientist I to contribute to global health through quality control testing that ensures the safety and efficacy of pharmaceutical products.
• You will perform chemical, physical, and microbiological analyses in support of manufacturing operations while following Good Manufacturing Practices (GMP).
• Working with advanced analytical instruments, you’ll conduct testing of raw materials, in-process samples, finished products, and stability samples.
• Our collaborative environment provides opportunities for continuous learning and career growth as you help deliver vital therapies to patients.

Duties and Responsibilities:

• Performs a variety of microbiological and bioanalytical testing; including Sterility Testing Bacterial, Endotoxin Testing, Particulate Matter, membrane filtration, TOC and conductivity to support release of product and making quality decisions.
• Generates valid data, document testing procedures and results in appropriate notebooks and database according to cGMP
• Compares laboratory results with specifications for acceptability and determines with QA and Management if repetition or OOS is required.
• Maintains equipment and laboratory cleanliness and report any issues to supervisor.
• Conducts tasks in a safe manner.
• Follows scheduled assigned activities to meet Client dates for customer needs.
• Interacts effectively with teams across departments and functions to increase efficiency, solve problems, generate cost savings and improve quality.
• Performs all duties in strict compliance with Safety guidelines and procedures, Standard Operating Procedures, Good Manufacturing Practices and Good Laboratory Practices.
• Maintains the necessary compliance status required by company.

Qualifications:

• Bachelor’s degree required, no prior experience required.
• Preferred Fields of Study: Chemistry, Biology, Biochemistry or related scientific field.
• Experience with microbiological identifications, testing, environmental monitoring, and aseptic techniques.
• Knowledge of GMP regulations, documentation practices, and pharmaceutical quality standards.
• Strong attention to detail with ability to follow standard procedures and maintain data integrity
• Excellent problem-solving skills and logical approach to scientific challenges.
• Proficient computer skills including Microsoft Office and laboratory information systems.
• Strong written and verbal communication abilities.
• Ability to work both independently and collaboratively in a dynamic environment.
• Physical requirements include standing/walking for extended periods, lifting up to 50 lbs, and manual dexterity.
• Must be able to work in cleanroom environments wearing required PPE.
• Ability to work various shifts including nights, weekends, and holidays as needed.
• Experience in pharmaceutical/regulated environment preferred but not required.

Physical Requirements:

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations.
• Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds.
• Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time.
• Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time.
• Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
• Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.